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Oral Candida in Infants and Dietary Type

NCT ID: NCT01438983

Last Updated: 2011-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-06-30

Brief Summary

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This is an observational, non-randomised trial to evaluate the effect of dietary type on infants oral candida colonization the investigators evaluated 90 infants in 1-24 months (45 breastfeeding and 45 bottle feeding infants) who attended to Yazd clinic for regular pediatric appointment. Infants with unremarkable health histories, normal weight, free of sign or symptom of oral candidiasis or other mucosal disease. Their mothers were also healthy and without sign or symptom of vagina or mammary candidiasis. Pacifier usage, use of antibiotics in last months, sign or symptom of oral candidiasis in infants or vagina and mammary candidiasis in mothers were exclusion criteria.

Detailed Description

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After filling in a questionnaire about infants dietary intake, age and sex and their mothers education level and health condition, a pre-moistened sterile cotton swab was taken from dorsal surface of tongue and mid-plate. The swabs were cultured in agar plate containing sabourauds dextrose agar medium with chloramphenicol, and kept in 37 C for 48 hours. The number of candida colonies was counted and germ tube test performed to separate candida albicans from other types. The data was collected and analyzed by SPSS software and chi-square, logistic regression and mann-whitney test. Study hypothesis: feeding by mothers milk reduces oral candida colonization.

Conditions

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Oral Candida Breastfeeding Bottle Feeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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breastfeeding infants

No interventions assigned to this group

bottle feeding infants

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* healthy infants
* healthy mothers

Exclusion Criteria

* pacifier usage
* use of antibiotics in last month
* sign or symptom of oral candidiasis in infants
* vagina and mammary candidiasis in mothers
Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Sadoughi University of Medical Sciences and Health Services

OTHER

Sponsor Role lead

Responsible Party

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Nastaran Azimi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nastaran azimi, dr

Role: PRINCIPAL_INVESTIGATOR

shahid sadoughi university of medical sciences and health science

Locations

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Nastaran Azimi

Yazd, Yazd Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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uni43

Identifier Type: -

Identifier Source: org_study_id